Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108,508
- 试验地点
- 290
- 主要终点
- Proportion of women diagnosed with an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of follow up after the last screen
研究概览
简要总结
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
详细描述
PRIMARY OBJECTIVES:
I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4).
SECONDARY OBJECTIVES:
I. To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.
II. To compare the diagnostic performance of TM and DM, as measured by the area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of childbearing potential must not be known to be pregnant or lactating
- •Patients must be scheduled for, or have intent to schedule, a screening mammogram
- •Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol.
- •Patients must be willing and able to provide a written informed consent
- •Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
- •Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
- •Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
- •Patients must not have breast enhancements (e.g., implants or injections)
- •ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
- •To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:
- •Patients are pre-menopausal; OR
- •Post-menopausal aged 45-69 with any of the following three risks factors:
- •Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
- •Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
- •Currently on hormone therapy; OR
- •Post-menopausal ages 70-74 with either of the following two risk factors:
- •Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
- •Currently on hormone therapy
- •Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
- •All other postmenopausal women are eligible for inclusion in the biennial screening regimen
- •For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist?s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic DM portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
- •Breast density will be determined by prior mammography reports, when available; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report
排除标准
- 未提供
研究组 & 干预措施
Arm A (digital mammography)
Patients undergo bilateral screening DM with standard CC and MLO views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
干预措施: Laboratory Biomarker Analysis (Other)
Arm A (digital mammography)
Patients undergo bilateral screening DM with standard CC and MLO views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
干预措施: Digital Mammography (Procedure)
Arm B (digital tomosynthesis mammography)
Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
干预措施: Digital Tomosynthesis Mammography (Procedure)
Arm B (digital tomosynthesis mammography)
Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Proportion of women diagnosed with an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of follow up after the last screen
时间窗: 4.5 years after last registration
The cumulative proportions of participants experiencing the primary endpoint in the two study arms will be compared. The primary comparison of the two study arms will be approached from an Intent-to-Treat perspective and will be based on a two-sided test for comparing binomial proportions.
次要结局
- Health care utilization (including cancer care received) of an episode of breast cancer screening by tomosynthesis mammography (TM) versus digital mammography (DM)(Up to 8 years)
- Diagnostic and predictive performance of tomosynthesis mammography (TM) and digital mammography (DM) [AUC](Up to 8 years)
- Task-based measure of image quality(Up to 8 years)
- Agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the five years of screening(Up to 8 years)
- Assess the predictive performance of tomosynthesis mammography (TM) and digital mammography (DM)(Up to 8 years)
- Health care costs (including diagnostic procedures and cancer care received) as the result of an episode of breast cancer screening by tomosynthesis mammography (TM) versus digital mammography (DM)(Up to 8 years)
- Breast-cancer-specific mortality(Up to 8 years)
- Prevalence of breast cancer subtypes (luminal A, luminal B, HER2+, basal-like) and p53 signature in the two arms(Up to 8 years)
- Breast Imaging-Reporting and Data System (BIRADS) imaging features(Up to 8 years)
- Centralized quality control (QC) monitoring program implementation(Up to 8 years)
- Histologically malignant (true positive cases) and benign lesions (false positive cases)(Up to 8 years)
- Quality control (QC) tests useful for determination of image quality and those that are predictive of device failure(Up to 8 years)
- Biopsy rates(Up to 8 years)
- Variability of quality control parameters(Up to 8 years)
- Rate of interval cancers(Up to 8 years)
- Recall rates(Up to 8 years)
- Proportion of women diagnosed with an ?advanced? breast cancer in the two arms(Up to 8 years)